Genentech alums launch a new biotechnology company; Mallinckrodt sues the FDA over a drug reclassification; Sanofi takes on celiac disease
Precision medicine is a guiding force for many pipelines, but a study shows a gap between developing drugs with biomarkers as well as tests that match patients to treatments.
An economist wants $37 billion invested in antibiotic development; Roche plans to file an experimental lung-cancer drug with the FDA this year; Sandoz wants compensation for lost Zarxio sales
Mylan weighs Teva takeover; GSK and UNC launch research center and drug company; FDA approves Roche colorectal cancer drug diagnostic
An FDA panel said heart risks should be part of Onglyza's label; the OIG will examine generic price increases; Abbott said its OTC glucose meter will save patients money
The snag: identifying what qualifies as download-worthy.
The goal is to develop companion diagnostics to match patients with cancer treatments.
Cologuard was the first approved fecal-based screening test for the disease, and it was also the first product the FDA and CMS approved on the very same day through the so-called Parallel Review program.
AstraZeneca's hope is that the blood test could replace tissue samples and be used to identify patients who could benefit from its lung drugs.
The Carlyle Group has picked up Johnson & Johnson's Ortho Diagnostics for $4B.
Covidien is buying ingestible-camera company Given Imaging.
Research suggests ADHD is becoming a regular fixture in adolescence. At the same time, publishers and startups have developed increasingly complex tools to separate patients from abusers.
Regulators say the company has not received approval for the device's touted functions.
The agency issued final guidance on mobile apps, saying it will focus only on a subset that present the greatest risk to patients if they don't work correctly.
Proteus Digital Health's ingestible sensor shows utility as an adherence tool for those on psych meds, a study suggests.
23andMe aired its first TV ad Monday, in a bid to build the audience for DNA sequencing.
Lundbeck and Otsuka prime Alzheimer's med for Phase III trials; Abbott reports Q2 results; and an FDA panel shrugs off Merck's muscle relaxant for another day.
The drug maker's third round of testing will focus on mild Alzheimer's patients. Candidates must test positive for beta amyloid.
The diagnostic firm is looking to expand its Cobas HPV diagnostic into first-line use, possibly edging out the older Pap test.
Roche buys diagnostics firm, and a study shows women are major mHealth users; plus: librarians enlisted to help navigate healthcare reform.
Medical science liaisons will educate nuclear-medicine clinicians as part of the launch of a new Navidea diagnostic agent for use in breast and skin cancer.
Two studies show that it's not enough to focus on cost to alter healthcare.
Internet trends show fondness for online health information, but no need for docs to take on a third job, Millennium says diabetes device market to grow moderately over five years.
Publisher UBM spurs medical competition among psychiatrists, Bayer says it's keeping its diabetes division.
GSK, Pfizer and Shionogi's HIV medication to get its day in regulatory court; Philips finds that mobile and health are becoming inseparable.
OraSure, the maker of the recently-approved home HIV test, has hired an experienced consumer marketer from Pfizer to head up the launch as it readies a TV ad campaign.
Diagnostics firm MedMira gets a contract from the US Army to develop a screening tool, and the FDA proposes some new device guidelines.
As the big cancer meeting wound down, talk turned to the best way to prepare Bristol-Myers Squibb's anti-PD-1 antibody, a potential blockbuster, for launch.
The CDC's proposal that all US baby boomers get a one-time test for the hepatitis C virus has already given a boost to drugmakers in the antiviral space.
Endo is restructuring, bringing its four operating units under the same corporate roof and rebranding to reflect its diversification out of its origins in pain and urology drugs.
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